General strategies in process development for recombinant protein production and purification in different host systems with a special focus on state-of-the-art methods to improve down-stream process development by implementing design of experiments and quality by design aspects, e.g. in clarification and chromatographic purification is presented.
Typical processes will be discussed using real-life equipment and examples. Specifically, we will first discuss (clean room) environments and the corresponding installations necessary to produce recombinant proteins under good manufacturing practice (GMP) conditions. Next, we will have a detailed look at typical bioprocess devices including individual advantages and drawbacks. Then, the potential organisms that can be used for manufacturing are compared focusing on product requirements. Lastly, we will discuss how all aspects can be combined to build scalable bioprocesses for vaccine manufacturing.